Rockwell Medical, Inc. Reports Third Quarter 2019 Financial Results
– Company reports first full quarter of results for Dialysate Triferic, highlighted by greater than 75% conversion rate from Triferic Evaluation Program –
– Signs leading
“Our mission is to transform anemia management in a wide variety of disease states across the globe while improving patients’ lives. We believe Triferic is one of the most innovative advancements in patient iron management over the last two decades. Accordingly, we are building the foundation to become a leading medical and commercial organization in the field of dialysis, which we believe will enable Triferic to become, over time, the standard of care for ESRD patients. We are pleased with the early progress we are making with the commercialization of our Triferic portfolio,” stated
Recent Business and Financial Highlights:
- Key highlights for the Dialysate Triferic U.S. market introduction include:
○ 1,000+ patients on therapy at 13 contracted clinics as ofSeptember 30, 2019 ;
○ 1,300+ patients on therapy at 15 clinics enrolled in the Evaluation Program;
○ Since launch, experienced 75% conversion rate of clinics in Evaluation Program; and
○ The Company entered into its first contract with a Center of Excellence1 (“COE”) for the purchase of Dialysate Triferic. - Appointed industry veteran
John P. McLaughlin as Chairman of the Board of Directors, bringing over 30 years of executive and board experience in the biopharmaceutical industry; - Continued to engage with the
U.S. Food and Drug Administration (“FDA”) on review activities regarding the I.V. Triferic New Drug Application (“NDA”), with a PDUFA date ofMarch 28, 2020 ; - Committed to enhancing the Company’s medical capabilities to build a leading medical platform in the field of dialysis;
- Sales were
$15.4 million and$45.8 million for the three and nine months endedSeptember 30, 2019 , respectively, including sales of Dialysate Triferic of approximately$98,000 and$112,000 , respectively; and - As of
September 30, 2019 , the Company had approximately$29.0 million of cash and cash equivalents and investments available-for-sale.
“We recognize that transforming to a new therapy from a well-entrenched approach takes time. As we build the foundation to achieve our mission, both in the U.S. and internationally, we are off to a promising start, and will continue to dedicate our resources to ensuring that hemodialysis patients have access to this innovative therapeutic,” concluded Paul.
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1 The Company defines Centers of Excellence as leading independent academic institutions that operate their own clinics or leading nephrology practices that are recognized as thought leaders in dialysis.
Third Quarter 2019 Financial Results
Net loss for the third quarter of 2019 was
Net sales for the third quarter of 2019 were
Cost of sales during the three months ended
Selling and marketing expenses were
General and administrative expenses were
Research and product development expenses were
Other income for the three months ended
The Company encourages shareholders to also review its Form 10-Q for the quarter ended
Conference Call
As previously announced,
Date | Monday, November 11, 2019 | |||
Time | 4:30 PM EST | |||
Telephone | U.S: | (877) 383-7438 | ||
International: | (678) 894-3975 | |||
Webcast (live and archive) | https://edge.media-server.com/mmc/p/kxajr6w6 |
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About
About Triferic
Triferic is the only
Important Safety Information
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving Triferic in two randomized clinical trials.
Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.
The most common adverse reactions (≥3% and at least 1% greater than placebo) in controlled clinical studies include: procedural hypotension (21.6%), muscle spasms (9.6%), headache (9.2%), pain in extremity (6.8%), peripheral edema (6.8%), dyspnea (5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous (AV) fistula thrombosis (3.4%), and AV fistula site hemorrhage (3.4%).
For more information, including full prescribing information, visit: http://www.triferic.com.
Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell Medical’s intention to bring to market Triferic, and I.V. Triferic. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "plan," "potential," "predict," "forecast," "project," "plan", "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While
Triferic® is a registered trademark of
Contact
Investor Relations:
T: 212-452-2793
E: lwilson@insitecony.com
Source:
Financial Tables Follow
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
September 30, | December 31, | |||||||
2019 | 2018 | |||||||
(Unaudited) | ||||||||
ASSETS | ||||||||
Cash and Cash Equivalents | $ | 14,421,394 | $ | 22,713,980 | ||||
Investments Available-for -Sale | 14,575,589 | 10,818,059 | ||||||
Accounts Receivable, net | 5,122,453 | 6,979,514 | ||||||
Insurance Receivable | — | 371,217 | ||||||
Inventory | 3,583,452 | 4,038,778 | ||||||
Prepaid and Other Current Assets | 2,861,708 | 1,903,682 | ||||||
Total Current Assets | 40,564,596 | 46,825,230 | ||||||
Property and Equipment, net | 2,506,093 | 2,638,293 | ||||||
Inventory, Non-Current | 528,000 | 1,637,000 | ||||||
Right of Use Assets, net | 3,011,805 | — | ||||||
Goodwill | 920,745 | 920,745 | ||||||
Other Non-current Assets | 555,933 | 536,516 | ||||||
Total Assets | $ | 48,087,172 | $ | 52,557,784 | ||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
Accounts Payable | $ | 3,194,039 | $ | 4,492,071 | ||||
Accrued Liabilities | 3,916,069 | 5,129,761 | ||||||
Settlement Payable | 270,000 | 416,668 | ||||||
Lease Liability - Current | 1,482,441 | — | ||||||
Deferred License Revenue - Current | 2,238,450 | 2,252,868 | ||||||
Insurance Financing Note Payable | 1,145,133 | — | ||||||
Customer Deposits | 48,163 | 63,143 | ||||||
Other Current Liability - Related Party | 100,000 | 850,000 | ||||||
Total Current Liabilities | 12,394,295 | 13,204,511 | ||||||
Lease Liability - Long-Term | 1,589,098 | — | ||||||
Deferred License Revenue - Long-Term | 10,401,166 | 12,076,399 | ||||||
Total Liabilities | 24,384,559 | 25,280,910 | ||||||
Shareholders’ Equity: | ||||||||
Preferred Shares, $.0001 par value, no shares issued and outstanding at September 30, 2019 and December 31, 2018 |
— | — | ||||||
Common Shares, $.0001 par value; 170,000,000 shares authorized; 63,887,384 and 57,034,154 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively |
6,389 | 5,703 | ||||||
Additional paid-in capital | 322,837,353 | 299,596,257 | ||||||
Accumulated Deficit | (299,213,836 | ) | (272,388,234 | ) | ||||
Accumulated Other Comprehensive Income | 72,707 | 63,148 | ||||||
Total Shareholders’ Equity | 23,702,613 | 27,276,874 | ||||||
Total Liabilities And Shareholders’ Equity | $ | 48,087,172 | $ | 52,557,784 | ||||
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES | ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months Ended September 30, 2019 |
Three Months Ended September 30, 2018 |
Nine Months Ended September 30, 2019 |
Nine Months Ended September 30, 2018 |
|||||||||||||
Net Sales | $ | 15,407,248 | $ | 16,672,416 | $ | 45,812,475 | $ | 46,534,358 | ||||||||
Cost of Sales | 15,423,612 | 14,703,606 | 44,085,298 | 49,303,048 | ||||||||||||
Gross Profit (Loss) | (16,364 | ) | 1,968,810 | 1,727,177 | (2,768,690 | ) | ||||||||||
Selling and Marketing | 1,827,473 | 121,874 | 7,148,848 | 716,414 | ||||||||||||
General and Administrative | 4,623,503 | 6,037,267 | 16,340,672 | 14,465,634 | ||||||||||||
Settlement Expense | — | — | 430,000 | 1,030,000 | ||||||||||||
Research and Product Development | 1,474,735 | 808,192 | 4,930,287 | 4,033,494 | ||||||||||||
Operating Loss | (7,942,075 | ) | (4,998,523 | ) | (27,122,630 | ) | (23,014,232 | ) | ||||||||
Other Income | ||||||||||||||||
Realized Gain (Loss) on Investments | 6,268 | (97,027 | ) | 24,292 | (222,014 | ) | ||||||||||
Interest Income, net | 80,735 | 125,918 | 272,736 | 486,301 | ||||||||||||
Total Other Income | 87,003 | 28,891 | 297,028 | 264,287 | ||||||||||||
Net Loss | $ | (7,855,072 | ) | $ | (4,969,632 | ) | $ | (26,825,602 | ) | $ | (22,749,945 | ) | ||||
Basic and Diluted Net Loss per Share | $ | (0.12 | ) | $ | (0.10 | ) | $ | (0.45 | ) | $ | (0.44 | ) | ||||
Basic and Diluted Weighted Average Shares Outstanding |
63,796,723 | 51,288,537 | 59,728,446 | 51,288,462 | ||||||||||||
Source: Rockwell Medical, Inc.